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NCT Number: NCT07427927

Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes

This retrospective, single-center observational study will use routinely collected perioperative data from adults undergoing surgery for symptomatic hemorrhoidal disease to identify data-driven clinical phenotypes. Unsupervised machine learning will be applied to characterize clusters of patients based on demographic, clinical, anatomical, and surgical variables. The study will explore whether the resulting phenotypes differ in operative complexity and postoperative course, and will generate hypotheses to inform future predictive models and personalized surgical planning.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

About this study

Hemorrhoidal disease presents with heterogeneous symptom patterns, anatomical findings, and operative strategies that are not fully captured by traditional degree-based classifications. This study aims to identify latent, clinically interpretable phenotypes among surgical patients using a fully unsupervised machine learning pipeline applied to routinely collected perioperative data from a high-volume tertiary referral center.

This is a retrospective, observational analysis of de-identified institutional records. The analytic dataset will include routinely documented variables spanning baseline demographics/anthropometrics, symptom profile and relevant clinical history, operative technique and intraoperative descriptors, and routinely captured postoperative follow-up information. Data will be extracted using a predefined data dictionary and standardized preprocessing rules to support reproducibility and reduce variability in variable definitions.

The primary analytic approach will be unsupervised clustering. Variables will be cleaned and standardized prior to modeling. Dimensionality reduction will be performed using t-distributed stochastic neighbor embedding (t-SNE), initialized with principal component analysis to improve stability. Cluster discovery will then be conducted using k-means clustering on the reduced feature space. A range of cluster solutions will be explored, and the final solution will be selected using internal validity metrics (e.g., silhouette-based measures) together with assessment of clinical interpretability. Model robustness will be evaluated through repeated runs across multiple random seeds and key parameter settings to assess stability of cluster assignments.

After cluster assignment, clusters will be characterized using descriptive and comparative statistics to identify variables that most differentiate phenotypes. Post-hoc feature relevance/importance approaches will be used to explore which demographic, clinical, and surgical factors most strongly contribute to cluster formation, with emphasis on effect sizes and clinically meaningful patterns rather than hypothesis-testing alone. Findings will be used to generate hypotheses regarding phenotypes that may be associated with greater operative complexity and different postoperative trajectories, supporting future work on predictive modeling and individualized surgical decision support.

All analyses will be conducted within a controlled institutional environment using validated statistical and data-mining software, with documented parameter settings and version tracking to enable reproducibility. Only de-identified data will be used for analysis, and results will be reported in aggregate to protect patient privacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Clinical and/or intraoperative diagnosis of symptomatic hemorrhoidal disease
  • Availability of complete perioperative data: demographic, clinical, surgical, and postoperative variables Exclusion criteria
  • Incomplete or missing clinical data
  • Presence of anorectal neoplastic conditions (e.g., anal or rectal carcinoma)
  • Anorectal surgery within the previous 6 months (to avoid confounding effects on symptoms and anatomy)

Treatment and study plan

Any surgical procedure for hemorrhoidal disease

Procedure

standard hemorrhoidectomy, advanced hemorrhoidectomy, prolapsectomy, Doppler-guided procedures, or combined techniques

Primary outcomes

  1. Internal validity of the unsupervised clustering solution (silhouette coefficient)

    Time frame: From completion of dataset extraction/cleaning through completion of clustering analysis (retrospective analysis of surgeries performed December 2024 to June 2025)

    Silhouette coefficient of the final k-means clustering solution derived from t-SNE-reduced perioperative data. The silhouette coefficient will be used as the primary internal validity metric to quantify cluster cohesion and separation for the selected number of clusters.

Secondary outcomes

  1. Cluster stability and reproducibility across model runs

    Time frame: From completion of dataset extraction/cleaning through completion of clustering robustness analyses (retrospective analysis of surgeries performed December 2024 to June 2025)

    Stability of cluster assignments across multiple random seeds and t-SNE parameter settings (including perplexity), summarized by reproducibility/consistency of membership and stability of internal validity metrics across runs.

  2. Operative duration (proxy of operative complexity)

    Time frame: Intraoperative (day of surgery)

    Operative duration (minutes) recorded in the operative report/perioperative database; compared across identified phenotypes.

  3. Postoperative pain intensity

    Time frame: From surgery to 6 month postoperatively

    Pain intensity as documented in routine postoperative records/follow-up notes (e.g., numeric rating scale when available or clinician-documented pain status), analyzed as pain trajectory/pattern across early and intermediate follow-up and compared across clusters.

  4. Postoperative complications (Clavien-Dindo classification)

    Time frame: From surgery to 1 month postoperatively (early complications) and up to 6 months postoperatively (late complications)

    Any postoperative complication recorded in routine follow-up, graded according to the Clavien-Dindo system; complication rates and severity compared across clusters.

  5. Time to return to routine activities

    Time frame: From surgery to 1 month postoperatively

    Time to return to routine activities/work when documented in follow-up notes; compared across phenotypes.

  6. Recurrence

    Time frame: 1 month and 6 months postoperatively

    Recurrence patterns or persistence/return of hemorrhoid-related symptoms (e.g., bleeding/prolapse/other symptoms) as documented in routine follow-up and need for re-evaluation or additional intervention; compared across clusters.

Other outcomes

  1. Cluster separation metrics (beyond silhouette)

    Time frame: From completion of dataset extraction/cleaning through completion of clustering analysis (retrospective analysis of surgeries performed December 2024 to June 2025)

    Additional internal cluster separation metrics (e.g., measures of between-cluster separation/within-cluster dispersion as implemented in the analytic workflow) reported to support interpretability of the phenotype solution.

  2. Between-cluster differences in clinical/anatomical/surgical characteristics

    Time frame: Baseline (preoperative assessment) and intraoperative (day of surgery)

    Differences across clusters in routinely collected demographic and clinical history variables (e.g., age, sex, BMI, comorbidity burden, medications, symptom profile, bowel habit characteristics), anatomical descriptors (when documented), and procedure type/technique selection.

  3. Post-hoc feature relevance for cluster formation

    Time frame: From completion of dataset extraction/cleaning through completion of post-hoc feature relevance analyses (retrospective analysis of surgeries performed December 2024 to June 2025)

    Relative contribution/importance of demographic, clinical, and surgical variables to cluster formation assessed using post-hoc feature relevance approaches; used to interpret drivers of phenotype structure.

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Acronym: PROCTO-CLUSTER

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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